Interstitial energy treatment probe holders

ABSTRACT

An interstitial laser energy treatment apparatus having co-acting movable probe holders which facilitate positioning of a laser probe and thermal probe in different positions relative to a tissue mass such as the tumor to be treated and relative to each other to facilitate treating tissue masses based on the exact position, size and shape of the tissue mass.

PRIORITY CLAIM

This application is a non-provisional application of, claims priority toand the benefit of U.S. Provisional Patent Application No. 60/888,223,filed Feb. 5, 2007, the entire contents of which are incorporated hereinby reference.

DESCRIPTION

The present disclosure relates in general to apparatus and methods fordelivering ablative laser energy to tissue such as tumors, and inparticular to apparatus and methods for positioning a laser probe todeliver ablative laser energy to tissue and for positioning a thermalprobe relative to the laser probe to monitor the temperature ofsurrounding tissue.

BACKGROUND

Percutaneous in situ or on-site laser therapy treatment of tissue suchas tumors and in particular malignant breast tumors can be more readilyperformed today because tissue abnormalities such as tumors are beingdetected at earlier stages. Tissue abnormalities such as breast cancerand other cancers or tumors detected in early development can beeffectively treated or destroyed using an ablative agent such as laserenergy without conventional surgery.

Interstitial laser energy treatments of tissue (such as tumors)including malignant tumors (such as breast, liver, brain, and necktumors), have been in development for more than a decade. For example,U.S. Pat. No. 5,169,396, U.S. Pat. No. 5,222,953, U.S. Pat. No.5,569,240, U.S. Pat. No. 5,853,366, U.S. Pat. No. 6,603,988, U.S. Pat.No. 6,701,175, U.S. Pat. No. 6,865,412, U.S. Pat. No. 7,041,109, andU.S. Pat. No. 7,171,253 disclose various apparatus and methods forconducting interstitial laser energy treatments of tissue (such astumors). Certain of these patents disclose a laser probe and a thermalprobe for conducting the interstitial laser energy treatment and relatedtemperature measurement. Certain of these patents also disclose a probeholder configured to hold the laser probe and the thermal probe.However, such probe holders are very limited in the relative positionsand fixed geometries in which they can hold the laser probe and thethermal probe for conducting interstitial laser energy treatment.Certain of these patents disclose a probe holder configured to hold thethermal probe at a single fixed distance from the laser probe and in asingle plane with the laser probe.

It has been determined that known probe holders do not fully facilitateinterstitial laser energy treatment of: (a) body parts of differentsizes and shapes (such as breasts) containing the tissue to be treated;(b) tissue to be treated (such as tumors) of different sizes and shapes;(c) different areas of the body containing the tissue to be treated; and(d) variations in the tissue surrounding the area to be treated. Theseknown probe holders also do not enable operators to properly account forvariations in the tissue surrounding the area to be ablated.Accordingly, there is a need for methods and apparatus for interstitiallaser energy treatment having a probe holder apparatus which facilitatesthe above variations.

SUMMARY

One embodiment of the present disclosure provides an interstitial laserenergy treatment apparatus having probe holder apparatus includingco-acting independently movable probe holders which facilitatepositioning of a laser probe in a suitable position relative to tissue(such as a tumor) to be treated and which facilitate positioning of athermal probe in a plurality of different positions and geometriesrelative to the tissue to be treated and relative to the laser probe.The probe holders enable operators to consistently and reliably positionthe thermal probe at different, predetermined distances from laser probeand to position the thermal probe together with the laser probe inmultiple different planes throughout a known or predetermined geometry.The movable probe holders enable an operator to: (a) place the laserprobe in the body of a patient in a desired position for treating thetissue based on the exact position, size, and shape of the tissue andthe body pan containing the tissue and (b) place the thermal probe inthe body of a patient in proximity with and substantially parallel tothe laser probe based on the position of the laser probe, the exactposition, size, and shape of the tissue to be treated, and the body partcontaining the tissue. This positioning enables the laser probe tofacilitate delivery of laser energy to the tissue and the thermal probeto measure the tissue temperature at various locations in proximity ofthe tissue (such as the tumor) being treated during interstitial lasertherapy. This positioning also enables the operator to account forvariations in tissue surrounding the area to be ablated.

It is therefore an advantage of the present disclosure to provide aninterstitial laser energy treatment apparatus having probe holderapparatus including one or more probe holders which facilitatepositioning of a laser probe and a thermal probe in desired positionsrelative to the tissue to be treated and relative to each other forinterstitial laser energy treatment.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary perspective view of one embodiment of theinterstitial laser energy treatment apparatus disclosed herein,illustrating the laser probe holders respectively aligned in firstpositions for positioning the laser probe and thermal probe in a firstplane relative to tissue.

FIG. 2 is an enlarged fragmentary perspective view of the embodiment ofthe interstitial laser energy treatment apparatus of FIG. 1, showing thelaser probe holders respectively aligned in different second positions(than those shown in FIG. 1) for positioning the laser probe and thermalprobe in a different second plane relative to the tissue.

FIG. 3 is an enlarged fragmentary perspective view of the embodiment ofthe interstitial laser energy treatment apparatus of FIG. 1, showing thelaser probe holders respectively aligned in the first positions (as inFIG. 1) and with the thermal probe at a further distance from the laserprobe than in FIG. 1.

FIG. 4 is an enlarged perspective view of the embodiment of one of thelaser probe holders of FIG. 1, shown removed from the interstitial laserenergy treatment apparatus, illustrating a laser probe channel and thethree spaced-apart thermal probe channels.

FIG. 5 is a side view of the embodiment of the laser probe holder ofFIG. 4, shown removed from the interstitial laser energy treatmentapparatus, illustrating in phantom the aligned laser probe channels andthe three spaced-apart thermal probe channels.

FIG. 6 is a top plan view of the embodiment of the laser probe holder ofFIG. 4, shown removed from the interstitial laser energy treatmentapparatus, illustrating the aligned laser probe channels and the threespaced-apart thermal probe channels.

FIG. 7 is an enlarged perspective view of an alternative embodiment ofthe laser probe holder, shown removed from the interstitial laser energytreatment apparatus, illustrating the aligned laser probe channels andthe two spaced-apart thermal probe channels.

FIG. 8 is a side view of the embodiment of the laser probe holder ofFIG. 7, shown removed from the interstitial laser energy treatmentapparatus, illustrating in phantom the aligned laser probe channels andthe two spaced-apart thermal probe channels.

FIG. 9 is top plan view of the embodiment of the laser probe holder ofFIG. 7, shown removed from the interstitial laser energy treatmentapparatus, illustrating the aligned laser probe channels and the twospaced-apart thermal probe channels.

FIG. 10 is a top plan view of an alternative embodiment of the laserprobe holder, shown removed from the interstitial laser energy treatmentapparatus, illustrating the aligned laser probe channels and fourspaced-apart thermal probe channels including three thermal probechannels adjacent to the laser probe channels and a fourth thermal probechannel spaced further apart from the three thermal channels.

FIG. 11 is a side view of the embodiment of the laser probe holder ofFIG. 10, shown removed from the interstitial laser energy treatmentapparatus, illustrating in phantom the aligned laser probe channel andthe four spaced-apart thermal probe channels.

FIGS. 12A, 12B, and 12C are top plan views of a set of probe holders ofa further alternative embodiment, each probe holder having one thermalprobe channel.

FIG. 13 is a side view of two connected probe holders of a furtheralternative embodiment.

FIG. 14 is a side view of an elongated probe holder of a furtheralternative embodiment.

FIG. 15 is a top perspective view of a further embodiment of the probeholder.

FIG. 16 is a side view of the embodiment of the probe holder of FIG. 15.

FIG. 17 is a fragmentary perspective view of another embodiment of theinterstitial laser energy treatment apparatus disclosed herein,illustrating the laser probe holders of FIGS. 15 and 16 respectivelyaligned in first positions for positioning the laser probe and thermalprobe in a first plane relative to tissue.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring now to the drawings, and particularly to FIGS. 1, 2, 3, 4, 5,and 6, one embodiment of the interstitial laser energy treatmentapparatus 10 is shown attached to or mounted on an imaging device orunit such as a conventional rotatable or positionable digitalmammography device or unit 12. The mammography unit 12 includes asuitable stereotactic device or unit 14. It should be appreciated thatthe imaging device or unit may be any suitable unit or device includingbut not limited to x-ray, ultrasound, or magnetic resource imagingdevices. It should also be appreciated that the stereotactic device orunit may be any suitable device or unit. The illustrated stereotacticdevice 14 includes conventional aligned extendable upper (or first) andlower (or second) biopsy needle holders 16 and 18, respectively,suitably attached at the bottom of the stereotactic device 14. Theillustrated stereotactic device 14 includes a compression plate 20suitably attached at the bottom of the stereotactic device 14 below theupper and lower biopsy needle holders 16 and 18. For ease ofillustration, FIGS. 1, 2 and 3, show a saline bag instead of a body part(such as a breast) containing the tissue which would be treated usingthe interstitial laser energy treatment apparatus.

The upper and lower biopsy needle holders 16 and 18 include outwardlyextending aligned movable upper and lower needle holder arms 22 and 24,respectively, which are conventionally configured to removably hold andposition a biopsy needle (not shown). The end sections of the arms 22and 24 have vertically aligned vertically extending apertures throughwhich the biopsy needle (not shown) is inserted for positioning andinsertion into a body part (such as a breast) to perform a biopsy. Thesearms are employed in conjunction with the probe holders as describedbelow to accurately and consistently position the laser probe andthermal probe of the interstitial laser therapy apparatus. It should beappreciated that the holders and arms can be configured in othersuitable manners. As illustrated in FIGS. 1, 2 and 3, the upper andlower probe holders 50 and 52 of the interstitial laser energy treatmentapparatus 10 are configured to be positioned at the end sections of theupper and lower needle holder arms 22 and 24 respectively to position alaser probe 100 and the thermal probe 102 for interstitial laser energytreatment. In certain embodiments disclosed herein the probe holders 50and 52 are not connected to facilitate independent positioning relativeto the movable arms which for different patients may be positioned atdifferent distances from each other.

More specifically, the probe holders 50 and 52 are preferably identicalin shape size and material. However, they may be varied in shape, sizeand material. FIGS. 4, 5 and 6 are used to illustrate both probe holders50 and 52, but are discussed particularly with reference to probe holder50. In one embodiment, the probe holder 50 generally includes agenerally rectangular solid plastic body having a length, width, anddepth. It should be appreciated that the probe holder may be formed inalternative shapes as further discussed below. The body of the probeholder 50 includes a top wall or surface 54, a bottom wall or surface56, a front wall or surface 58, a rear wall or surface 60, and two sidewalls or surfaces 62 and 64. The rear or first portion or section of thebody includes or defines a needle holder arm receiving area 66 sized andconfigured to receive the end section of the respective needle holderarm as illustrated. The rear or first portion or section of the bodyalso defines or includes vertically aligned laser probe receivingchannels 70 a and 70 b positioned in the body on opposite sides of thearm receiving area 66. Channel 70 a extends from the top surface or wall54 to a top wall 71 a which defines the arm receiving area 66 andchannel 70 b extends from the bottom wall or surface 56 to a bottom wall71 b which defines the arm receiving area 66. The probe holder 50 alsoincludes a front or second portion or section defining spaced-apartparallel or substantially parallel thermal probe receiving channels 72,74, and 76 extending from the top wall or surface 54 to the bottom wallor surface 56.

In the embodiments illustrated herein, all of the laser probe andthermal probe channels are cylindrical; however, it should beappreciated that one or more of the channels may be formed in othersuitable shapes and that different channels may be of different shapes.It should also be appreciated that the spacing between the channels mayvary. It should further be appreciated that each of the size of thechannels, shape of the channels, number of channels, and distancebetween the channels may vary depending on the type of procedure forwhich the channels are employed.

Referring again to FIGS. 1 and 2, the illustrated embodiment of theinterstitual laser treatment apparatus 10 includes a laser probe 100 anda temperature or thermal probe 102 configured to be held in position bythe upper probe holder 50 positioned at the end of the upper needleholder arm 22 and a lower probe holder 52 positioned at the end of thelower needle holder arm 24. The upper and lower probe holders are shownaligned in first positions in FIG. 1 and in different second positionsin FIG. 2 to illustrate that the interstitial laser apparatus disclosedherein facilitates the thermal probe and laser probe being aligned invarious different vertical planes in a geometry about the axis of thelaser probe. It should be appreciated that the thermal probe may bealigned in one of a plurality of different planes with respect to thelaser probe. In the illustrated embodiment, the different planes eachextend in an arc or partial arc around the axis of rotation of the laserprobe as further discussed below.

In operation, the laser probe 100 is removably inserted through theneedle arm apertures (not shown) and the laser probe channels of thealigned probe holders, and the thermal probe 102 is removably insertedthrough one of the sets of the aligned corresponding thermal probechannels of the aligned probe holders 50 and 52. The thermal probe 102is held in fixed position or distance relative to the laser probe 100 bythe probe holders 50 and 52. The thermal probe 102 is also held suchthat it remains co-planar or substantially co-planar with the laserprobe 100.

More specifically, to position the laser probe 100, the operatorpositions the upper probe holder 50 at the end of the upper needleholder arm 22 such that laser probe channels 70 a and 70 b (of the upperprobe holder 50) are vertically aligned with the aperture of thevertically extending arm 22 (i.e., above and below the end of the arm22). The operator then inserts the laser probe 100 through the laserprobe channel 70 a, then through the aperture of the arm 22, and thenthrough the laser probe channel 70 b. It should be appreciated that inthis embodiment the probe holder 50 is maintained in position relativeto the arm 22 by the laser probe 100 once inserted. At this point, theprobe holder 50 is pivotally movable about the axis of the laser probe.

In this embodiment, the operator then positions the lower probe holder52 at the end of the lower needle holder arm 24 such that laser probechannels 70 a and 70 b (of the lower probe holder 52) are verticallyaligned with the aperture of the vertically extending arm 24 (i.e.,above and below the end of the arm 24). The operator then pushes down onthe laser probe to insert the laser probe 100 through the laser probechannel 70 a (of the lower probe holder 52), then through the apertureof the arm 24, and then through the laser probe channel 7 b (of thelower probe holder 52). It should be appreciated that in this embodimentthe probe holder 52 is maintained in position relative to the arm 22 bythe laser probe 100 once inserted. At this point, the probe holder 52 ispivotally movable about the axis of the laser probe.

It should thus be appreciated that when the laser probe 100 is insertedthrough both probe holders 50 and 52 and through the arms 22 and 24, theprobe holders 50 and 52 are each configured to independently to pivotabout an axis of rotation extending substantially along the length ofthe laser probe 100. This enables the operator to position the laserprobe holders in any one of a plurality of the different sets ofpositions relative to the laser probe. The operator can position theprobe holders to select the plane in which the laser probe and thermalprobe will be aligned.

For example, FIG. 1 shows the probe holders 50 and 52 aligned in a setof first positions or first plane. FIG. 2 shows the probe holders 50 and52 aligned in a set of second positions (which are different than thefirst set of positions) and thus in a second, different plane. Thedetermination of which positions and which planes will be used is atleast in part based on the size and shape of the tissue (such as thetumor) being treated and at least in part based on where such tissue islocated.

To position the thermal probe 102, the operator selects one of therespective sets of thermal probe channels in the probe holders based onthe operator's desired distance between the thermal probe 102 and thelaser probe 100. This determination is also in part based on the size,shape of the tissue (such as the tumor) being treated and at least inpart based on where such tissue is located. The operator inserts thethermal probe 102 through the selected set of thermal probe channels 72,74, or 76 in the respective probe holders 50 and 52.

In one embodiment, the laser probe is inserted through the probe holdersand arms, into the body part (such as the breast), and into the tissueto be treated (such as the tumor) before the thermal probe is insertedthrough the probe holders.

In another embodiment, the laser probe is inserted through the probeholders and arms but not into the body part (such as the breast) or intothe tissue to be treated (such as the tumor) before the thermal probe isinserted through the probe holders, in this embodiment, after the laserprobe and thermal probe are positioned, both are inserted into thepatient. Also, in this embodiment, after inserting the laser probe, theoperator may move the thermal probe to a different set of thermal probechannels before inserting the thermal probe into the patient.

It should be appreciated that the probe holders may be made from anysuitable material such as a suitable plastic, a suitable metal, asuitable composite material, or any combination thereof. It ispreferable that the probe holders are made of a material and are sizedsuch that they do not interfere with the imaging device or unit. Itshould also be appreciated that the probe holder apparatus disclosedherein enable the probe holders to be easily moved or rotated out of theway of the imaging device.

Turning now to FIGS. 7, 8, and 9, an alternative embodiment of the probeholder generally indicated by numeral 150 is illustrated. Probe holder150 is similar to probe holder 50 as illustrated in FIGS. 4, 5, and 6,except that it has one fewer thermal probe receiving channel. It shouldthus be appreciated that the number of thermal probe receiving channelscan vary in accordance with various embodiments of the presentdisclosure. More specifically, probe holder 150 includes a generallyrectangular solid body having a top wall or surface 154, a bottom wallor surface 156, a front wall or surface 158, a rear wall or surface 160,and two side walls or surfaces 162 and 164. The rear portion of the bodyincludes a needle holder arm receiving area 166 sized and configured toreceive the end section of the respective needle holder arm. The probeholder body defines or includes vertically aligned laser probe receivingchannels 170 a and 170 b and spaced-apart parallel thermal probereceiving channels 172 and 174.

It should be appreciated that the shape of the body of the probe holdermay also vary. FIGS. 10 and 11 illustrate an alternative embodiment ofthe probe holder generally indicated by numeral 250 in which the rearsection (having the laser probe channels) is wider than the frontsection (having the thermal probe channels). The probe holder 250 alsoillustrates one extra thermal probe channel than illustrated in FIGS. 4,5, and 6, and that the thermal probe channels may be spaced in differentpatterns and that they may be spaced-apart at different distances. Morespecifically, the probe holder 250 includes a top wall or surface 254, abottom wall or surface 256, a front wall or surface 258, a rear wall orsurface 260, and two side walls or surfaces 262 and 264. The rear orfirst portion or section defines a needle holder arm receiving area 266.The rear or first portion or section also defines or includes verticallyaligned laser probe receiving channels 270 a and 270 b. The probe holder250 also includes spaced-apart parallel or substantially parallelthermal probe receiving channels 272, 274, 276, and 278.

In another embodiment as illustrated in FIGS. 12A, 128, and 12C, theprobe holders are provided as a set of probe holders such as probeholders 350A, 350B, and 350C. The respective distances A, B, and Cbetween the respective laser probe channels and the thermal probechannels differ for each probe holder 350A, 350B, and 350C. In thisembodiment, the set of probe holders includes two probe holders 350A,two probe holders 350B, and two probe holders 350C. In this embodimentthe operator selects and uses the desired pair of probe holders 350A350B, or 350C, depending on the desired distance between the laser probeand the thermal probe.

In a further alternative embodiment as illustrated in FIG. 13, theindividual probe holders 450 and 452 are suitably connect by at leastone connection member or bar 451. The connection member or bar 451 holdsthe probe holders 450 and 452 together. This embodiment enables theoperator to place or position both probe holders 450 and 452 together onthe biopsy needle holder arms. In one such embodiment, the connectionmember or bar 451 is suitably removable. This removable functionalitymay be provided in any suitable manner. It should be appreciated thatthe connection member will be formed and positioned so as not tointerfere with the probes before, during, or after positioning the probeholder.

In a further embodiment illustrated in FIG. 14 the probe holder 550 iselongated, enabling it to be simultaneously positioned adjacent to bothbiopsy needle holders or arms. The probe holder is formed as one bodyand thus performs the same function as the separate probe holdersdescribed above. In one such embodiment, the two probe holders areintegrally formed. The body of the probe holder 550 includes a top wallor surface 554, a bottom wall or surfaces 556, a front wall or surface558, a rear wall or surface 560, and two side walls or surfaces 562 and564 (not shown). The rear or first portion or section of the bodyincludes or defines needle holder arm receiving areas 566 a and 566 beach sized and configured to receive the end section of the respectivebiopsy needle holder arms. The rear or first portion or section of thebody also defines or includes vertically aligned laser probe receivingchannels 570 a, 570 b and 570 c. The probe holder 550 also includes afront or second portion or section defining spaced-apart parallel orsubstantially parallel thermal probe receiving channels 572, 574, and576 extending from the top wall or surface 554 to the bottom wall orsurface 556. This embodiment can be used in certain situations where thedistance between the biopsy needle holder arms is fixed. Alternatively,a set of these probe holders 550 may be provided such that each probeholder has a different distance between arm receiving areas 566 a and566 b.

In a further embodiment, illustrated in FIGS. 15, 16, and 17, the probeholder 650 includes a body having a top wall or surface 654, a bottomwall or surface 656, a front wall or surface 658, a rear wall or surface660, and two side walls or surfaces 662 and 664 (not shown). The rear orfirst portion or section of the body includes or defines an integratedbushing 666 for rotatably connecting the probe holder 650 to the biopsyneedle holder arm. The integrated bushing 666 for rotatably connectingthe probe holder 650 to the biopsy needle holder arm is positioned inthe aperture of the arm 22. The rear or first portion or section of thebody also includes or defines a vertically aligned laser probe receivingchannel 670. The front or second portion or section of the body includesor defines vertically aligned thermal probe receiving channels 672, 674,and 676. It should be appreciated that in this embodiment, the probeholder 650 is maintained in position relative to the arm 22 by theintegrated bushing 666 once inserted into the arm 22. Similarly, asillustrated in FIG. 17, the second probe holder 652 includes anintegrated bushing 666 for rotatably connecting the probe holder 652 tothe biopsy needle holder arm 24. It should be appreciated that the probeholders 650 and 652 are each pivotally movable with respect to thebiopsy needle holder arms 22 and 24.

It should thus be appreciated that in operation, an operator positionsboth of the probe holders 650 and 652 in the arms 22 and 24respectively, and then inserts the laser probe 100 through the laserprobe channel 670 of probe holder 650, which is rotatably inserted inthe aperture of the arm 22, and then through the laser probe channel 670of probe holder 652. It should be appreciated that in this embodiment,the laser probes do not come in contact with the arms. This embodimentalso more easily enables an operator to position the probe holders andthen the probes.

It should also be appreciated that FIG. 17 illustrates a slightlymodified connection box 700 for the laser probe and thermal probe.Specifically, FIG. 17 illustrates that both the laser fiber and the wirefor transferring temperature data from the single thermistor on thelaser are contained within a single cord enclosure. In this embodiment,the number of discrete cords or cables terminating at either of the twoprobes is thus reduced.

In one embodiment, the tissue (such as the tumor) is pierced with alaser probe to enable access to the tissue by a saline supply and alaser fiber for interstitial laser energy treatment. In one embodiment,the laser heats the tumor tissue using saline as a heat transfer medium.The thermal probe measures the temperature of the tissue adjacent to thetissue being treated.

More specifically, the illustrated embodiment of the interstitial lasertreatment apparatus further includes a y-connector attached to the laserprobe 100, which is configured to received a laser fiber and a salinesupply tube. The laser fiber is connected to a suitable laser diodesource such as one having 1-8 watts, 805 nominal nanometer wavelength.The saline supply tube is connected to a suitable syringe infusion pump(not shown) such as one capable of accurately dispensing 60 cc syringesof saline at variable flow rates to 1 cc per minute, continuouslyadjustable, and including bolus function. In one embodiment, the laserprobe is a 14 gauge probe constructed of 304 stainless steel and has onethermistor attached. It should be appreciated that the number ofthermistors may vary. In one embodiment, the thermal probe is a 14 gaugeprobe constructed of 304 stainless steel and has five thermistorsattached. In one such embodiment, the thermistors are marked andreferred to as T1, T2, T3, T4, and T5 (not shown).

In one embodiment, the interstitial laser treatment apparatus furtherincludes a converter suitable to convert thermistor temperature to adigital signal. The laser probe is placed in the desired position withrespect to the tissue to be treated (such as in the center of thetumor). In one embodiment, the laser probe contains the optical fiber,and thus guides laser energy, a temperature measuring device, and salinesolution to the interior of the tissue (such as the tumor). The thermalprobe is inserted in the probe holder such that it is positioned in theperiphery of the tissue to be treated (such as the tumor). The thermalprobe enables the operator to determine the tissue temperature at setdistances from the tissue being treated and monitor the varioustemperatures.

Tissue temperature measurements are taken at various distances away fromthe tumor mass surface. This temperature data is utilized in conjunctionwith the relative distances of the temperature sensors to calculate thevolume of tumor mass destroyed, and therefore is utilized to determinewhen the entire tumor mass is effectively destroyed, as discussed below.Enabling the operator to optimally position the thermal probe withrespect to the laser probe is critical to enable the operator to monitora concentric zone of heat emitted from the tip of the laser probe duringtreatment. The ability to monitor the concentric heat patterns of thelaser probe is necessary to effectively measure the volume of tissue(such as the tumor) mass destroyed during treatment.

As previously discussed the relative positioning of the thermal probeand the laser probe must be determined and known to accurately calculatethe volume of tumor mass destroyed. The thermal probe and laser probemay include a number of position marks (not shown) to enable an operatordetermine the relative positions of the thermal probe and laser probe.The position marks are preferably evenly spaced-apart along a portion ofa length of the thermal probe and along a portion of the length of thelaser probe. The operator may use these position marks to correctlyposition the laser probe, and subsequently position the thermal proberelative to the laser probe, as each probe is inserted in one of theprobe receiving channels in the probe holders.

It should also be appreciated that a conventional treatment platform(not shown) may be positioned relative to the imaging device or unit toenable the interstitial laser therapy to be performed while the patient(not shown) is lying on the treatment platform. The use of the treatmentplatform with the imaging unit enables the interstitial laser therapy tobe performed and, if necessary, adjunctive therapy to be performed inthe same treatment room without transferring the patient to a newplatform as described in one of the patents mentioned above.

It should be appreciated that the present disclosure is not limited tointerstitial last energy therapy, and particularly, interstitial laserenergy therapy for the destruction of a breast tumor. The presentdisclosure may apply to a variety of different non-surgical treatmentsfor the destruction of a variety of different tumor masses.

It should be understood that modifications and variations may beeffected without departing from the scope of the novel concepts of thepresent disclosure, and it should be understood that this application isto be limited only by the scope of the appended claims.

1. An interstitial energy treatment probe holder comprising: a bodyhaving a first section including a top-most portion and a bottom-mostportion, and a second section including a top-most portion and abottom-most portion, said first section including at least oneattachment arm removably attachable to at least one positioning arm of apositionable imaging unit, said first section defining one or moreenergy probe receiving channels, each energy probe receiving channelhaving a diameter larger than a diameter of an energy probe such thatthe energy probe can extend through any of the one or more energy probereceiving channels, through and beyond the top-most portion of the firstsection, and through and beyond the bottom-most portion of the firstsection, substantially along a first axis, and said second sectionconnected to the first section and defining a plurality of spaced-apartthermal probe receiving channels, including: (i) a first thermal probereceiving channel at a first predetermined distance from one of the oneor more energy probe receiving channels, the first predetermineddistance based on a first tissue to be treated, the first thermal probereceiving channel having a diameter larger than a diameter of a thermalprobe such that the thermal probe can extend through the first thermalprobe receiving channel, through and beyond the top-most portion of thesecond section, and through and beyond the bottom-most portion of thesecond section, substantially along a second axis, said second axisbeing different than the first axis, and (ii) a second thermal probereceiving channel at, second predetermined distance from said one of theone or more energy probe receiving channels, the second predetermineddistance based on a different second tissue to be treated, the secondthermal probe receiving channel having a diameter larger than thediameter of the thermal probe such that the thermal probe can extendthrough the second thermal probe receiving channel, through and beyondthe top-most portion of the second section, and through and beyond thebottom-most portion of the second section, substantially along a thirdaxis, said third axis being different than said first axis and differentthan said second axis, the second predetermined distance being greaterthan the first predetermined distance, and the first axis, the secondaxis, and the third axis being substantially co-planar, the bodyconfigured to: (a) hold the energy probe in an operator-selectedposition with respect to the positionable imaging unit during aninterstitial energy treatment, (b) hold the thermal probe at either thefirst predetermined distance from said energy probe or the secondpredetermined distance from said energy probe during said interstitialenergy treatment, and (c) hold both the energy probe and the thermalprobe in an operator-selected one of a plurality of different planes. 2.The interstitial energy treatment probe holder of claim 1, wherein theat least one positioning arm of the positionable imaging unit includes aneedle holder arm of a stereotactic device, and wherein the at least oneattachment arm of the first section includes a needle holder armreceiving area configured to receive an end section of the needle holderarm of the stereotactic device.
 3. The interstitial energy treatmentprobe holder of claim 2, wherein the first section of the body defines aplurality of energy probe receiving channels aligned along said firstaxis.
 4. The interstitial energy treatment probe holder of claim 1,wherein the first section of the body defines a plurality of energyprobe receiving channels aligned along said first axis.
 5. Theinterstitial energy treatment probe holder of claim 1, wherein the atleast one attachment arm of the first section includes an integratedbushing.
 6. The interstitial energy treatment probe holder of claim 1,wherein the positionable imaging unit includes a stereotactic device,and wherein the first section is removably attachable to at least oneneedle holder arm of the stereotactic device.
 7. The interstitial energytreatment probe holder of claim 1, wherein the plurality of spaced-apartthermal probe receiving channels are substantially parallel to eachother.
 8. The interstitial energy treatment probe holder of claim 7,wherein the each of the one or more energy probe receiving channels issubstantially parallel to each of the plurality of thermal probereceiving channels.
 9. The interstitial energy treatment probe holder ofclaim 1, wherein the body is configured to hold the thermal probe in asubstantially parallel manner to the energy probe during saidinterstitial energy treatment.
 10. The interstitial energy treatmentprobe holder of claim 1, wherein the first section is removablyattachable to the at least one positioning arm of the positionableimaging unit by surrounding a portion of the at least one positioningarm of the positionable imaging unit.
 11. The interstitial energytreatment probe holder of claim 1, wherein the at least one positioningarm of the positionable imaging unit includes a positionable imagingunit arm channel, and wherein the first section is removably attachableto the at least one positioning arm of the positionable imaging unit byaligning the positionable imaging unit arm channel with the energy probereceiving channel.
 12. An interstitial energy treatment probe holdercomprising: a body having a first section including a top-most portionand a bottom-most portion, and a second section including a top-mostportion and a bottom-most portion, said first section including at leastone attachment arm removably attachable to at least one positioning armof a positionable imaging unit, said first section defining an energyprobe receiving channel having a diameter larger than a diameter of anenergy probe, said energy probe receiving channel extendingsubstantially along a first axis and enabling the energy probe to extendthrough and beyond the top-most portion of the first section and throughand beyond the bottom-most portion of the first section, and said secondsection connected to the first section and defining a plurality ofspaced-apart thermal probe receiving channels, including: (i) a firstthermal probe receiving channel at a first predetermined distance fromthe energy probe receiving channel, the first predetermined distancebased on a first tissue to be treated, the first thermal probe receivingchannel having a diameter larger than a diameter of a thermal probe, thefirst thermal probe receiving channel extending substantially along asecond axis, said second axis different than said first axis, andenabling the thermal probe to extend through and beyond the top-mostportion of the second section and through and beyond the bottom-mostportion of the second section, and (ii) a second thermal probe receivingchannel at a second, predetermined distance from the energy probereceiving channel, the second predetermined distance based on adifferent second tissue to be treated, the second thermal probereceiving channel having a diameter larger than the diameter of thethermal probe, the second thermal probe receiving channel extendingsubstantially along a third axis, said third axis different than saidfirst axis and different than said second axis, and enabling the thermalprobe to extend through and beyond the top-most portion of the secondsection and through and beyond the bottom-most portion of the secondsection, the second predetermined distance being greater than the firstpredetermined distance and the first axis, the second axis, and thethird axis being substantially parallel and substantially co-planar. 13.The interstitial energy treatment probe holder of claim 12, wherein thefirst section defines at least one additional energy probe receivingchannel such that each of the plurality of spaced-apart thermal probereceiving channels is at a different predetermined distance from theadditional energy probe receiving channel and such that each of theplurality of spaced apart thermal probe receiving channels extendsparallel or substantially parallel to the at least one additional energyprobe receiving channel.
 14. The interstitial energy treatment probeholder of claim 12, wherein the at least one positioning arm of thepositionable imaging unit includes a needle holder arm of a stereotacticdevice and wherein a rear portion of the first section of the bodydefines a needle holder arm receiving area sized and configured toreceive an end section of the needle holder arm of the stereotacticdevice.
 15. The interstitial energy treatment probe holder of claim 14,wherein the first section of the body defines a plurality of energyprobe receiving channels aligned along said first axis.
 16. Theinterstitial energy treatment probe holder of claim 12, wherein thefirst section of the body defines a plurality of energy probe receivingchannels aligned along said first axis.
 17. The interstitial energytreatment probe holder of claim 12, wherein the at least one attachmentarm of the first section includes an integrated bushing.
 18. Theinterstitial energy treatment probe holder of claim 12, wherein thepositionable imaging unit includes a stereotactic device, and whereinthe first section is removably attachable to at least one needle holderarm of the stereotactic device.
 19. The interstitial energy treatmentprobe holder of claim 12, wherein the first section is removablyattachable to the at least one positioning arm of the positionableimaging unit by surrounding a portion of the at least one positioningarm of the positionable imaging unit.
 20. The interstitial energytreatment probe holder of claim 12, wherein the at least one positioningarm of the positionable imaging unit includes a positionable imagingunit arm channel, and wherein the first section is removably attachableto the at least one positioning arm of the positionable imaging unit byaligning the positionable imaging unit arm channel with the energy probereceiving channel.
 21. An interstitial energy treatment probe holdercomprising: a body having a first section including a top-most portionand a bottom-most portion, and a second section including a top-mostportion and a bottom-most portion, said first section including at leastone attachment arm removably attachable to at least one positioning armof a positionable imaging unit, said first section defining one or moreenergy probe receiving channels each having a diameter larger than adiameter of an energy probe, such that the energy probe extends canextend through any of the one or more energy probe receiving channels,through and beyond the top-most portion of the first section, andthrough and beyond the bottom-most portion of the first section,substantially along a first axis, and said second section connected tothe first section and defining at least one set of spaced-apart thermalprobe receiving channels, said at least one set of spaced-apart thermalprobe receiving channels including: (i) a first thermal probe receivingchannel at a first predetermined distance from one of the one or moreenergy probe receiving channels, the first predetermined distance basedon a first tissue to be treated, the first thermal probe receivingchannel having a diameter larger than a diameter of a thermal probe suchthat the thermal probe can extend through the first thermal probereceiving channel, through and beyond the top-most portion of the secondsection, and through and beyond the bottom-most portion of the secondsection, substantially along a second axis, said second axis differentfrom said first axis, and (ii) a second thermal probe receiving channelat a second, predetermined distance from said one of the one or moreenergy probe receiving channels, the second predetermined distance basedon a second tissue to be treated, the second thermal probe receivingchannel having a diameter larger than a diameter of the thermal probesuch that the thermal probe can extend through the second thermal probereceiving channel, through and beyond the top-most portion of the secondsection, and through and beyond the bottom-most portion of the secondsection, substantially along a third axis, said third axis differentfrom said first axis and said second axis, the second predetermineddistance being greater than the first predetermined distance, and thefirst axis, the second axis, and the third axis being substantiallycoplanar, the body configured to: (a) hold the energy probe in anoperator-selected position with respect to the positionable imaging unitduring an interstitial energy treatment using one of the one or moreenergy probe receiving channels, and (b) hold the thermal probe ateither the first predetermined distance from said energy probe or thesecond predetermined distance from said energy probe using either saidfirst thermal probe receiving channel or said second thermal probereceiving channel during said interstitial energy treatment.
 22. Theinterstitial energy treatment probe holder of claim 21, wherein the atleast one positioning arm of the positionable imaging unit includes aneedle holder arm of a stereotactic device, and wherein a rear portionof the first section of the body defines a needle holder arm receivingarea configured to receive an end section of the needle holder arm ofthe stereotactic device.
 23. The interstitial energy treatment probeholder of claim 22, wherein the first section of the body defines aplurality of energy probe receiving channels aligned along the firstaxis.
 24. The interstitial energy treatment probe holder of claim 22,wherein the at least one attachment arm of the first section includes anintegrated bushing.
 25. The interstitial energy treatment probe holderof claim 21, wherein the first section of the body defines a pluralityof energy probe receiving channels aligned along the first axis.
 26. Theinterstitial energy treatment probe holder of claim 21, wherein thepositionable imaging unit includes a stereotactic device, and whereinthe first section is removably attachable to at least one needle holderarm of the stereotactic device.
 27. The interstitial energy treatmentprobe holder of claim 21, wherein the thermal probe receiving channelsof the at least one set of thermal probe receiving channels aresubstantially parallel to each other.
 28. The interstitial energytreatment probe holder of claim 27, wherein the one or more energy probereceiving channels are each substantially parallel to the thermal probereceiving channels of the at least one set of thermal probe receivingchannels.
 29. The interstitial energy treatment probe holder of claim21, wherein the body is configured to hold the thermal probe in asubstantially parallel manner to the energy probe during saidinterstitial energy treatment.
 30. The interstitial energy treatmentprobe holder of claim 21, wherein the first section is removablyattachable to the at least one positioning arm of the positionableimaging unit by surrounding a portion of the at least one positioningarm of the positionable imaging unit.
 31. The interstitial energytreatment probe holder of claim 21, wherein the at least one positioningarm of the positionable imaging unit includes a positionable imagingunit arm channel, and wherein the first section is removably attachableto the at least one positioning arm of the positionable imaging unit byaligning the positionable imaging unit arm channel with the energy probereceiving channel.
 32. An interstitial energy treatment probe holdercomprising: a body having a first section including a top-most surfaceand a bottom-most surface, and a second section including a top-mostsurface and a bottom-most surface, said first section defining at leastone energy probe receiving channel, the at least one energy probereceiving channel configured to engage an energy probe such that theenergy probe extends through the at least one energy probe receivingchannel, through and beyond the top-most surface of the first section,and through and beyond the bottom-most surface of the first section,substantially along a first axis, and said second section connected tothe first section and defining at least one thermal probe receivingchannel including a first thermal probe receiving channel at a firstpredetermined distance from the energy probe receiving channel, thefirst predetermined distance based on a first tissue to be treated, thefirst thermal probe receiving channel configured to engage a thermalprobe such that the thermal probe can extend through the first thermalprobe receiving channel, through and beyond the top-most surface of thesecond section, and through and beyond the bottom-most surface of thesecond section, substantially along a second axis, said second axisdifferent than said first axis, the first axis and the second axis beingsubstantially co-planar, the body configured to: (a) engage the energyprobe in a user selected position with respect to the thermal probeduring an interstitial energy treatment, and (b) engage the thermalprobe at the first predetermined distance from the energy probe duringsaid interstitial energy treatment in a user selected one of a pluralityof different planes.
 33. The interstitial energy treatment probe holderof claim 32, wherein: (a) the first section includes at least oneattachment arm removably attachable to a supporting structure, (b) thesupporting structure includes a needle holder arm of a stereotacticdevice of a positionable imaging unit, and (c) the first section definesa needle holder arm receiving area configured to receive an end sectionof the needle holder arm of the stereotactic device of the supportingstructure.
 34. The interstitial energy treatment probe holder of claim32, wherein the second section defines a plurality of thermal probereceiving channels aligned along said second axis.
 35. The interstitialenergy treatment probe holder of claim 32, wherein the second sectiondefines a plurality of aligned energy probe receiving channels alignedalong said first axis.
 36. The interstitial energy treatment probeholder of claim 32, wherein the second section includes a second thermalprobe receiving channel at a second predetermined distance from theenergy probe receiving channel, the second predetermined distance basedon a second tissue to be treated, the second thermal probe receivingchannel configured to engage a thermal probe such that the thermal probecan extend through the second thermal probe receiving channel, throughand beyond the top-most surface of the second section, and through andbeyond the bottom-most surface of the second section, substantiallyalong a third axis, said third axis different than said first axis anddifferent than said second axis, the first axis, the second axis, andthe third axis being substantially co-planar, the second predetermineddistance being greater than the first predetermined distance, and thebody configured to hold the thermal probe at either the firstpredetermined distance from said energy probe or the secondpredetermined distance from said energy probe during said interstitialenergy treatment.
 37. The interstitial energy treatment probe holder ofclaim 33, wherein the first section is removably attachable to the atleast one positioning arm of the supporting structure by surrounding aportion of the at least one positioning arm of the supporting structure.